(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Unique identifier (udi) #: n/a.Concomitant medical products: 00434903600, poly liner, lot 63028247; 00434903611, glenosphere, lot 63076788; 00434902502, base plate, lot 62514115.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-01061; 0001822565-2019-01062; 0001822565-2019-01063.
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It was reported that during the patient's primary surgery, a scalene block was administered, and the patient subsequently developed pneumothorax.The use of a chest tube was required to intervene, and the patient spent approximately 8 more days in the hospital due to the pneumothorax.Attempts have been made and no further information has been provided.
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